Bates et al.v.Speck et al.

Patent Trial and Appeal Board

Feb 18, 2016

14193312 (P.T.A.B. Feb. 18, 2016)

-1-
BoxInterferences@uspto.gov Entered: 18 February 2016
Tel: 571-272-4683

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

BRIAN L. BATES,
ANTHONY O. RAGHEB,
JOSEPH M. STEWART IV, WILLIAM J. BOURDEAU,
BRIAN D. CHOULES, JAMES D. PURDY, and
NEAL E. FEARNOT,
Junior Party
(Application 14/193,312),

v.

ULRICH SPECK
and BRUNO SCHELLER,
Senior Party
(Patent 8,389,043),

Patent Interference No. 106,044
(Technology Center 1600)

Before RICHARD E. SCHAFER, SALLY GARDNER LANE, and
DEBORAH KATZ, Administrative Patent Judges.

LANE, Administrative Patent Judge.

JUDGMENT - Bd. R. 127(a)

-2-
The Board determined that Speck failed to show why judgment should not 1
be entered against it given the judgment adverse to Speck in prior interference 2
105,787. (Decision, Paper 48). 3
Accordingly, 4
It is ORDERED that judgment on priority is entered against senior party 5
Speck as to Count 1, the sole Count, of the interference (Declaration, Paper 1, at 6
5); 7
FURTHER ORDERED that claims 1-37 of Speck patent 8,389,043, which 8
correspond to Count 1, are CANCELLED. 35 U.S.C. § 135(a);1 9
FURTHER ORDERED that the parties are directed to 35 USC § 135(c) and 10
Bd. R. 205 regarding the filing of settlement agreements; 11
FURTHER ORDERED that a party seeking judicial review timely serve 12
notice on the Director of the United States Patent and Trademark Office. 13
37 C.F.R. §§ 90.1 and 104.2. See also Bd. R. 8(b). Attention is directed to Biogen 14
Idec MA, Inc., v. Japanese Foundation for Cancer Research, 785 F.3d 648, 15
654–57 (Fed. Cir. 2015) (determining that pre-AIA § 146 review was eliminated 16
for interference proceedings declared after September 15, 2012); and 17
FURTHER ORDERED that a copy of this judgment be entered into the 18
administrative records of the involved Speck patent and Bates application. 19

1 Any reference to a statute in this Judgment is to the statute that was in effect
on March 15, 2013 unless otherwise indicated. See Pub. L. 112-29, § 3(n), 125
Stat. 284, 293 (2011).

-3-

cc (via e-mail):

Attorney for Bates:

Christopher A. Brown
Kenneth A. Gandy
WOODARD, EMHARDT, MORIARTY,
McNETT & HENRY LLP
cabrown@uspatent.com
kgandy@uspatent.com

Attorney for Speck:

Bryan P. Collins
Jack S. Barufka
PILLSBURY WINTHROP SHAW PITTMAN LLP
bryan.collins@pillsburylaw.com
jack.barufka@pillsburylaw.com

-1-
BoxInterferences@uspto.gov Entered: 18 February 2016
Tel: 571-272-4683

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

BRIAN L. BATES,
ANTHONY O. RAGHEB,
JOSEPH M. STEWART IV, WILLIAM J. BOURDEAU,
BRIAN D. CHOULES, JAMES D. PURDY, and
NEAL E. FEARNOT,
Junior Party
(Application 14/193,312),

v.

ULRICH SPECK
and BRUNO SCHELLER,
Senior Party
(Patent 8,389,043),

Patent Interference No. 106,044
(Technology Center 1600)

Before RICHARD E. SCHAFER, SALLY GARDNER LANE, and
DEBORAH KATZ, Administrative Patent Judges.

LANE, Administrative Patent Judge.

DECISON – Bd. R. 104(a)

-2-
I. Background 1
Prior to this interference the parties were involved in interference 105,787 2
(’787), declared 17 November 2010 (’787 Declaration, Paper 1). The ’787 3
interference involved Bates patent 7,803,149 (’149), issued from a parent 4
application to the Bates currently involved application and Speck application 5
11/763,125 (’125), a parent application to the Speck currently involved patent. In 6
the ’787 interference, judgment on priority was entered against party Speck. As a 7
result Speck’s only claim, claim 100, which was also the Count of the interference, 8
was finally refused. (’787 Judgment, Paper 52; ’787 Redeclaration, Paper 48, at 1). 9
Upon declaration of the present interference (Declaration, Paper 1), Speck 10
was ordered to show cause why judgment should not be issued against it in this 11
interference given the judgment against Speck in the ’787 interference. (Show 12
Cause Order, Paper 3). 13
Speck filed a response to the Order to Show Cause (Speck Response, Paper 14
16).1 We determine that Speck has not shown sufficient cause why judgment 15
should not be entered against it on the basis of estoppel by judgment of the ’787 16
interference. 17
18

1 Bates was authorized to file, and did file, an opposition to that
response. (Authorization, Paper 27, Bates Opposition, Paper 30). Speck was
authorized to file, and did file, a Reply to the Bates Opposition. (Authorization,
Paper 41, Speck Reply, Paper 42). Thereafter Bates requested and was given
authorization to file a two page Surreply. (Authorization, Paper 43, Surreply,
Paper 44).

-3-
II. Findings of Fact 1
The record supports the following findings of fact by a preponderance of the 2
evidence. 3
1. The Count of the ’787 interference was directed to “[c]laim 100 of Speck 4
wherein the lipophilic agent is paclitaxel.” (’787, Redeclaration, Paper 48). 5
2. Claim 100 of the Speck application involved in the ’787 interference was as 6
follows: 7
100. A method of delivering a lipophilic active agent which is 8
paclitaxel, docetaxel, or 7-(2”, 3” –dihydroxypropyl oxycarbonyl)-9
paclitaxel to an inner wall of a blood vessel of a patient from a balloon 10
catheter having an expandable balloon with the lipophilic active agent 11
on an outer surface of the balloon, the method comprising: 12
providing said expandable balloon of said balloon catheter, said 13
expandable balloon having an outer surface and a layer consisting of 14
dried lipophilic active agent which is paclitaxel, docetaxel, or 7-(2”, 15
3” –dihydroxypropyl oxycarbonyl)-paclitaxel on said outer surface of 16
said expandable balloon, said layer being the only layer on said outer 17
surface of said expandable balloon; and 18
employing said balloon catheter for vessel dilation. 19
20
(’787 Count, ’787 Redeclaration, Paper 48, at 1 and Speck Amendment, Paper 47, 21
at 2 (relevant language in bold)). 22
23
3. Claim 1 of the presently involved Speck patent reads as follows: 24
A method for making a drug-coated angioplasty catheter, 25
comprising: 26
applying a solution of a lipophilic drug directly to a surface of a 27
balloon wall of a balloon of an angioplasty catheter, and 28

-4-
drying the solution to form a coating of the lipophilic drug 1
directly on the balloon wall to provide an outermost surface over the 2
balloon, 3
wherein said solution comprises a solvent, said lipophilic 4
drug, and a contrast agent, and said lipophilic drug is selected from 5
azithromycin, roxithromycin, probucol, prostacyclins, corticoids, 6
rapamycin, colchicine, paclitaxel, docetaxel, and 7-7
(2'',3''dihydroxypropyl oxycarbonyl)-paclitaxel. 8
9
(Speck Clean Copy of Claims, Paper 14 (relevant language in bold)). 10
4. Speck claim 1 differs from the ’787 Count in that, inter alia, the outer layer 11
of the ’787 Count “consists of” the lipophilic active agent while the outer layer 12
(coating) of Speck claim 1 “comprises” a solvent, the lipophilic active agent (drug) 13
and a “contrast agent”. 14
5. In the ’787 interference claim 23 of Bates was designated as corresponding 15
to the ’787 Count. (’787 Redeclaration, Paper 48, at 2). 16
6. Claim 23 recites that the coating “further comprises” an iodine containing 17
radiopaque agent. (’787, Bates Clean Copy of Claims, Paper 6, at 6). 18
7. Iodine containing radiopaque agents are disclosed in the involved Speck 19
specification as being suitable contrast agents. (Speck Involved Patent, Ex 1001, 20
at, e.g., 3:61-4:2; 9:29-31). 21
8. Thus the Board, in the ’787 interference, concluded that the addition of a 22
contrast agent would have been obvious given the subject matter of the ’787 Count. 23
Bd. R. 207(b) (2). 24
9. In the ’787 interference, Bates moved for authorization to file a motion to 25
add to the ’787 interference the Speck application that became the Speck currently 26
involved patent, i.e., application 12/835,420. 27

-5-
10. Bates was not authorized to file such a motion because the application had 1
not yet been examined. (’787, Order Setting Times, Paper 19, at 5:1-7, referring to 2
Item B4 of the Bates Motions List, Paper 18, at 4; See also Bd. R. 102). 3
11. In the ’787 interference Speck cancelled its claims that allowed for inclusion 4
of a contrast agent after Bates proposed a motion to attack the patentability of these 5
claims for indefiniteness and lack of written description. (’787 Interference at 6
Speck Clean Copy of Claims, Paper 11; Speck First Amendment, Paper 22; Speck 7
Second Amendment, Paper 47; and Order Setting Times, Paper 19, at 3:9-19 8
(discussing Bates proposed motion)). 9
12. Prior to cancelling one of these claims Speck moved for authorization to file 10
a motion to add a second count to the ’787 interference directed to an outer layer 11
having a contrast agent, but authorization was denied as untimely requested. (See 12
’787 Interference at Decision, Paper 41, at 2; (Errata at Paper 44) and Order, Paper 13
43). 14
III. Discussion 15
Two types of estoppel may be applied against a losing party in an 16
interference. First, the losing party may be barred on the merits from seeking a 17
claim that would have been anticipated or rendered obvious by the subject matter 18
of the lost count. In re Deckler, 977 F.2d 1449 (Fed. Cir. 1992); Ex parte 19
Tytgat, 225 USPQ 907 (BPAI 1985). We refer to this type of interference 20
estoppel as estoppel by judgment. See Biogen MA, Inc. v. Japanese Foundation 21
for Cancer Research, 785 F.3d 648, 657 (Fed. Cir. 2015) (citing, inter alia, In re 22
Deckler at 1452 and MPEP § 2308.03 (9th ed. March 2014)). Secondly there is a 23
procedural estoppel that may apply such that a party may be barred from seeking 24
relief that could have been, but was not, sought in the interference. 37 C.F.R. 25

-6-
41.127(a) (1); Ex parte Kimura, 55 USPQ2d 1537, 1548 (BPAI 2000). Here if 1
estoppel by judgment applies then that alone is sufficient to estop Speck from 2
continuing the interference even if procedural estoppel does not apply. See Biogen 3
at 658. (“Even if Fiers’ filing of the motions to add the protein count would suffice 4
to avoid other forms of estoppel, it is irrelevant to estoppel by judgment.”). 5
Estoppel by judgment of interference ’787 6
Speck has the burden of showing why judgment should not be entered 7
against it in view of the judgment in the ’787 interference. Biogen at 858 (“We 8
agree with the Board that Fiers failed to meet his burden [of proof] to show 9
patentable distinctness to avoid [the] interference estoppel by judgment.”). In 10
particular, Speck has the burden of showing that its claims would not have been 11
anticipated or rendered obvious by the subject matter of the ’787 Count. 12
In the ’787 interference Bates claim 23 was designated as corresponding to 13
the Count. A claim corresponds to a count if the subject matter of the count, 14
treated as prior art to the claims, would have anticipated or rendered obvious the 15
subject matter of the claim. Bd. R. 207(b) (2). (FF2s 5-8). Thus, as Speck is 16
aware, the Board has already concluded that adding a contrast agent to the outer 17
layer would have been obvious in view of the ’787 Count. 18
In its Response to the Order to Show Cause, Speck notes that the ’787 Count 19
limits the outer layer to one “consisting of” the lipophilic active agent while its 20
presently involved claims do not so limit the outer layer but instead allow for 21
“something more, including at a minimum the recited ‘contrast agent’…and 22
potentially…other components because of the ‘comprising’ language.” Speck 23

2 Finding of fact.

-7-
argues that, therefore, its “involved claims and the Lost Count are not similar in 1
scope and cover mutually exclusive subject matter.” (Speck Response at 3:23-4:5). 2
We agree with Speck that the ’787 Count does not anticipate the presently 3
involved Speck claims since the ’787 Count does not allow for a contrast agent in 4
the outer layer. However, Speck’s argument in this regard does not address 5
whether the ’787 Count would have rendered obvious the presently involved Speck 6
claims. 7
Speck next argues that the ’787 Count and the Speck claims do not render 8
each other obvious based on “plain language” because the ’787 Count “express 9
‘consisting of’ exclusion against adding anything else to the layer besides the 10
‘dried lipophilic active agent’ contradicts adding a ‘contrast agent.’” (Speck 11
Response at 4:11-22). 12
Here Speck must prove a negative, i.e., that it would not have been obvious 13
to add a contrast agent to the outer layer. As we note in the Standing Order: 14
Proving that subject matter is not obvious may require a negative 15
proof: that no prior art in combination with the subject matter of the 16
count could render the claimed subject matter obvious. A party may 17
be able to satisfy its burden of production with testimony from a 18
knowledgeable witness certifying that there is no known prior art that 19
would have overcome the differences between the subject matter of 20
the count and the subject matter of the claim and that the differences 21
were not merely routine or conventional in the art. 22
23
(Standing Order at ¶ 208.1). 24
Speck does not direct us to “testimony from a knowledgeable witness” in 25
support of its argument against obviousness. Instead Speck relies upon the “plain 26
language” of the ’787 Count and its presently involved claims. We do not find this 27

-8-
argument persuasive. While the term “consisting of” limits the ’787 Count, it does 1
not limit what would have been obvious over this Count in view of the prior art. 2
Speck’s arguments are not supported by evidence sufficient to show that adding a 3
contrast agent would not have been obvious. The arguments of Speck counsel 4
cannot take the place of testimony or other evidence sufficient to show a lack of 5
obviousness. Estee Lauder Inc. v. L'Oreal, S.A., 129 F.3d 588, 595 (Fed. Cir. 6
1997). 7
Speck argues that the specifications of the involved Speck patent and Bates 8
application confirm patentable distinctness because these specifications discuss 9
surprising results obtained by addition of (Speck involved specification), or the 10
criticality of excluding (Bates involved specification), a contrast agent. (Speck 11
Response at 5:1-6:2 citing Speck specification, Ex 1001, at 3:45-51 and Bates 12
involved specification, Ex 1002, at ¶ 11, 12, 15, 19, 32, 66, and claims 1, 9, 14, 19 13
and 21 said to exclude containment or time release material). 14
We understand Speck’s argument to be that unexpected results are achieved 15
by the addition of a contrast agent such that its addition would not have been 16
obvious. The surprising benefits asserted within the Speck involved specification 17
(e.g., enhanced absorption, adhesion, and solubility) though are not evidence that 18
the benefits were obtained or that, if obtained, would have been unexpected. 19
Speck does not direct us to data or other evidence showing that the benefits were 20
obtained and were obtained when used within an outer coating of the claimed 21
balloon catheter. Nor has Speck shown that such benefits, if obtained, were 22
unexpected to one skilled in the art. Attorney arguments or conclusory statements 23
that are unsupported with factual evidence are not sufficient to establish 24
unexpected results. In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). 25

-9-
Accordingly, we do not find this argument persuasive to show a lack of 1
obviousness. 2
Speck argues that the Bates involved specification “repeatedly admonishes 3
against the addition of ‘containment materials’ such as those for controlling time- 4
release of the active drug” (Speck Response at 5:10-12). According to Speck these 5
admonitions “contradict and teach away from Speck’s involved claims and the 6
present Count, because their ‘comprising’ language permits the addition of such 7
materials for controlling time-release.” 8
Office records indicate that the Bates specification referred to in Speck’s 9
response, i.e., the Bates involved application specification, published on 26 June 10
2014, after the Speck involved patent’s application filing date of 13 July 2010. 11
Even when we consider the specification of junior party Bates to be prior art as to 12
the Speck involved claims, we are unpersuaded that the portion of the Bates’ 13
involved specification pointed out to us by Speck amounts to a teaching away from 14
the addition of a contrast agent. We have not been directed to evidence showing 15
that one skilled in the art would have considered the admonitions to teach away 16
from the addition of a contrast agent or a specific mention within the Bates 17
involved specification of the exclusion of a contrast agent. Further we note that 18
Bates includes within its involved claims a contrast agent and a solvent (Bates 19
Clean Copy of Claims, Paper 8, at e.g., claim 22) so at least these claims do not 20
support a teaching away. Accordingly, we do not find this argument persuasive to 21
show a lack of obviousness. 22
Finally Speck argues that the prosecution histories of the involved patent 23
applications confirm distinctness over the prior art because, according to Speck, 24
the Examiner determined that the inclusion of a contrast agent resulted in 25

-10-
allowability of the claims. (Speck Response at 6:8-7:19). 1
Without deciding the correctness of Speck’s characterization of the 2
Examiner’s reasons for allowance in each application, we note that the 3
determination by the Examiner was made in light of the prior art and not in view of 4
the ’787 Count in combination with the prior art as is the consideration before us. 5
Further, to the extent the Examiner had made such a consideration, neither the 6
Board nor Bates is bound by the Examiner’s ex parte determination. Glaxo 7
Wellcome, Inc. v. Cabilly, 56 USPQ2d 1983, 1984 (BPAI 2000). 8
We thus determine that Speck has not shown sufficient cause why it is not 9
estopped based on the judgment in the ’787 interference. 10
11
Procedural estoppel (under Bd. R. 127(a) (1)) 12
A losing party in an interference who properly could have move for relief on 13
an issue but did not so move is estopped to take action in the Office that is 14
inconsistent with that failure to move. Bd. R. 127(a). 15
Speck voluntarily cancelled claims including a contrast agent and did not 16
timely seek relief to include a count to subject matter that included a contrast agent. 17
(FFs 11 and 12). Nonetheless Speck argues that procedural estoppel does not 18
apply against it since Bates, in the ’787 interference, sought authorization to file a 19
motion to add the now involved Speck patent’s underlying application to that 20
interference. Speck notes that Bates was not authorized to file such a motion since 21
no claim of the application had been determined to be allowable by the Examiner. 22
(’787, Order Setting Times, Paper 19, at 5:1-11). Even though Speck did not itself 23
seek to add the application to the interference, Speck argues that it was clear that 24
the Board was not going to authorize a motion to add an application lacking 25

-11-
allowable subject matter. (Speck Response at 8:8-9:4). 1
Speck argues that in the ’787 interference it sought authorization to file a 2
motion to add a second count to include the addition of a contrast agent. That 3
motion though was denied because the request to file it was belated. (FF 12; See 4
also MPEP § 2308.03 (9th ed. March 2014) at example 8 regarding untimely 5
motions). 6
We do not find it necessary to resolve the issue of procedural estoppel. 7
Since we determine that the Speck claims are subject to estoppel by judgment, we 8
will enter judgment against Speck on this basis alone whether or not procedural 9
estoppel under Bd. R. 127(a) (1) also applies. Biogen at 658. 10
11
IV. Order 12
It is 13
ORDERED that Speck has not shown cause why judgment should not 14
be entered against it; and 15
FURTHER ORDERED that judgment shall be entered against Speck 16
in a separate paper. 17

-12-

cc (via e-mail):

Attorney for Bates:

Christopher A. Brown
Kenneth A. Gandy
WOODARD, EMHARDT, MORIARTY,
McNETT & HENRY LLP
cabrown@uspatent.com
kgandy@uspatent.com

Attorney for Speck:

Bryan P. Collins
Jack S. Barufka
PILLSBURY WINTHROP SHAW PITTMAN LLP
bryan.collins@pillsburylaw.com
jack.barufka@pillsburylaw.com